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FDA 510(k)

DRILL MODULES MODELS 2116/2117

K-Number: K914346 · 1991-11-27

ApplicantMicro Surgical Instruments Corp.
Decision Date1991-11-27
Product CodeERL
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

DRILL MODULES MODELS 2116/2117 is the device name listed in this FDA 510(k) record. The listed applicant is Micro Surgical Instruments Corp.. It received FDA 510(k) clearance on 1991-11-27 under 510(k) number K914346. The device is classified under product code ERL. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DRILL MODULES MODELS 2116/2117?

DRILL MODULES MODELS 2116/2117 is a medical device that received FDA 510(k) clearance on 1991-11-27. The listed applicant is Micro Surgical Instruments Corp.. The 510(k) number is K914346.

When did DRILL MODULES MODELS 2116/2117 receive FDA 510(k) clearance?

DRILL MODULES MODELS 2116/2117 received FDA 510(k) clearance on 1991-11-27, under 510(k) number K914346.

Who is the listed applicant for DRILL MODULES MODELS 2116/2117?

The FDA 510(k) record lists Micro Surgical Instruments Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DRILL MODULES MODELS 2116/2117?

The FDA product code for DRILL MODULES MODELS 2116/2117 is ERL.

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Other records listing Micro Surgical Instruments Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K931395SERIES 5000 BATTERY POWERED INSTRUMENT SYSTEMK932492IMPLANTOLOGY MODULE, MODEL 2175K930205ELECTRIC WIRE DRIVER, MODEL 2640EK914998MICROAIRE(R) FACIAL BONE PLATING SYSTEMK915139MODEL 2250-000 ZIMMER STYLE SAGITTAL SAW MODULEK913369MICRO-AIRE MODEL 2060

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Related Devices (Code: ERL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243280Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro instruments (various tips) and accessories)W&H Dentalwerk Buermoos GmbHK233958hekaDrillZethon, Ltd.K221184ORiGO SystemBien-Air Surgery SAK213221AMADEO, M-UK1015 (incl. attachments and accessories)W&H Dentalwerk Buermoss GmbHK212650Celeris, Disposable Sinus DebriderGyrus Acmi, Inc.K211490Pi Drive 2 Motor / Model Number 5407-150-000, Pi Drive 2 Plus Motor / Model Number 5407-350-000Stryker Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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